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510(k) Data Aggregation
K Number
K011031Manufacturer
Date Cleared
2001-08-03
(120 days)
Product Code
Regulation Number
866.6010Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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